FDA inspection
GE Healthcare - Repair Operations Center: FDA inspection ending Jul 18, 2023
FDA inspection 1210335 · Voluntary Action Indicated (VAI) · Oak Creek, WI
Key facts
| Inspection ID | 1210335 |
|---|---|
| Firm | GE Healthcare - Repair Operations Center |
| FEI number | 3013679558 |
| Address | 120 W Opus Dr Unit B |
| City | Oak Creek |
| State | WI |
| ZIP | 53154 |
| Country | United States |
| Fiscal year | 2023 |
| Inspection end date | Jul 18, 2023 |
| Classification | Voluntary Action Indicated (VAI) |
| Project area | Postmarket Assurance: Devices |
| Product type | Devices |
At a glance
- 1–9 Citations
- 1–9 Posted citations
- No Warning letter followed
- Yes Form FDA 483 issued
- No Establishment inspection report (EIR) exists
- 1–9 Inspections at this FEI
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA inspections
FDA inspections are classified as No Action Indicated (NAI), Voluntary Action Indicated (VAI) or Official Action Indicated (OAI). Inspections of individual clinical investigators are not published here.
Source: U.S. Food and Drug Administration (FDA), inspection classification data